METAMECH is a master observational protocol designed to empower a bi-directional collaboration between basic and clinical research, an essential prerequisite to feed and implement precision oncology.
METAMECH will follow a stage-mixed cohort of at least 500 patients through their course of treatments, until death or a minimum of 5 years. Patients will be longitudinally sampled and matched clinical data (including imaging) will be collected. Via a multi-tiered informed consensus process, METAMECH will also allow to develop companion diagnostics for molecular enrichment strategies in AIRC-driven proof-of-concept trials.
Verification that the patient could not be reached for informed consent in accordance with applicable national regulations or, alternatively, TIER1 written Informed consent.
Patients ≥18 years of age.
Previous diagnosis of breast cancer, or a strong suspicion of BC based on clinical and radiological findings.
ECOG Performance status < 2 (only for TIER1-2).
Any other current malignancy or malignancy diagnosed or relapsed within the past 5 years (other than non-melanomatous skin cancer, stage 0 melanoma in situ, and in situ cervical cancer)
Patient unable to comply with the study protocol owing to psychological, social or geographical reasons.
Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or syphilis infection.
Stage-mixed Breast Cancer (BC) patients
Other
Other
Observational
Other interventionRetrospective cohorts and Prospective observation of standard clinical practice
Number of patients recruited in TIER0 and TIER 1
Number of recruited BC cases in TIER 0 and in TIER 1 with complete clinically annotated FFPE and/or frozen biological samples
Number of patients recruited in TIER2
Number of recruited BC cases in TIER 2
Number of patients triaged in proof-of concept (POC) clinical trials
Number of BC cases recruited in TIER 3
New prognostic mechanotransduction-linked markers
Number of identified/validated new prognostic mechanotransduction-linked markers
New predictive mechanotransduction-linked markers
Number of identified/validated new predictive mechanotransduction-linked markers
Biomarkers correlation with RR
Correlation between identified biomarkers with therapies response rates (RR)
Biomarkers correlation with PFS
Correlation between identified biomarkers with progression-free survival (PFS)
Click on the lead sponsor to view all of their trials.
